Sampling devices and methods utilizing biased capillary action

• US 8,083,688 B2
• Filed: 02/16/2010
• Issued: 12/27/2011
• Est. Priority Date: 12/24/2002
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Steven N.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US12/706,015
• Publication Number:
  US 20100145228A1
• Time in Patent Office: 679 Days
• Field of Search: 600583-584, 600/573, 600/576, 606181-183
• US Class Current: 600/583
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52

Abstract

A device is constructed so as to define a capillary channel that draws a body fluid form a proximal portion of the capillary channel toward a distal portion. A counterbore defining a “ledge” not substantially normal to the center line of channel causes the meniscus of body fluid to be “biased” into a non-radially-symmetric shape. In one example, the bias draws the body fluid toward a testing element that is set into a groove in the main body of the device. In another example, hydrophilic and/or hydrophobic regions are created on or in device to produce the biasing effect. In certain configurations, device requires less blood to be drawn into the capillary channel for a successful test than if the biasing effect were not created.

Claims

1. A method, comprising:

providing a body fluid sampling device that includes

a capillary channel with a capillary channel wall with a first side and a second side that opposes the first side, wherein the capillary channel has a proximal end portion with a capillary channel opening and a distal end portion that extends opposite the proximal end portion, wherein the capillary channel extends from the proximal end portion to the distal end portion along a longitudinal axis,

a testing element disposed along the first side of the channel wall between the proximal end portion and the distal end portion, wherein the testing element and the channel wall are distinct from one another,

a lancet disposed within the capillary channel and defining a capillary space between the lancet and the channel wall of the body, wherein the channel wall of the capillary channel surrounds the lancet,

wherein the first side of the capillary channel wall has a relatively hydrophilic region that extends from the capillary channel opening to the testing element where the hydrophilic region ends, wherein the hydrophilic region has a higher hydrophilic affinity relative to the second side of the capillary channel wall, and

wherein the capillary channel defines a counterbore ending in a surface that is non-normal to the longitudinal axis of the capillary channel;

lancing an incision in tissue with the lancet by extending the lancet from the capillary channel opening;

drawing body fluid from the incision via capillary action into the capillary space, wherein the body fluid forms a meniscus in the capillary space;

biasing the meniscus in an asymmetric manner with the hydrophilic region and the counterbore towards the testing element, wherein the counterbore works in conjunction with the hydrophilic region to bias the body fluid towards the testing element to use less of the body fluid than would be required without biasing the body fluid in the asymmetric manner;

wherein the counterbore is angled in an asymmetric manner at the distal end portion of the capillary channel;

wherein the capillary channel has a diameter;

wherein the counterbore has a diameter larger than the diameter of the capillary channel;

wherein the testing element is disposed between the counterbore and the hydrophilic region;

wherein the hydrophilic region extends only from the capillary channel opening to the testing element, wherein the hydrophilic region ends at the testing element, wherein the hydrophilic region is absent along the capillary channel wall from the testing element towards the distal end portion; and

wherein said biasing meniscus includes ceasing flow of the body fluid at the testing element with the counterbore.

2. The method of claim 1, further comprising:

analyzing the body fluid with the testing element.

3. A device for sampling body fluid, comprising:

a body defining a capillary channel with a channel wall having a first side and a second side opposing the first side, the capillary channel having a proximal end portion with a capillary channel opening where the body fluid is drawn into the capillary channel and a distal end portion that extends opposite the proximal end portion, wherein the capillary channel extends from the proximal end portion to the distal end portion along a longitudinal axis;

a testing element disposed along the first side of the channel wall between the proximal end portion and the distal end portion, the testing element and the channel wall being distinct from one another;

a lancet disposed within the capillary channel and defining a capillary space between the lancet and the channel wall of the body, wherein the channel wall of the capillary channel surrounds the lancet, the capillary channel being dimensioned to draw the body fluid into the capillary space through capillary action;

the first side of the capillary channel wall having a relatively hydrophilic region that extends from the capillary channel opening to the testing element where the hydrophilic region ends, wherein the hydrophilic region has a higher hydrophilic affinity relative to the second side of the capillary channel wall to bias a meniscus of the body fluid toward the testing element when the body fluid is drawn into the space;

wherein the capillary channel defines a counterbore ending in a surface that is non-normal to the longitudinal axis of the capillary channel, wherein the counterbore works in conjunction with the hydrophilic region to bias the body fluid towards the testing element to use less of the body fluid than would be required without biasing the body fluid in an asymmetric manner;

wherein the counterbore is angled in an asymmetric manner at the distal end portion of the capillary channel;

wherein the capillary channel has a diameter;

wherein the counterbore has a diameter larger than the diameter of the capillary channel; and

wherein the testing element is disposed between the counterbore and the hydrophilic region, the counterbore being located at the distal end portion to inhibit the body fluid from flowing into the distal end portion.

4. The device of claim 3, wherein the proximal end portion and the distal end portion are shaped to draw the body fluid towards the test element.

5. The device of claim 4, wherein the proximal end portion and the distal end portion form a stepped-end counter bore.

6. The device of claim 4, wherein the proximal end portion and the distal end portion of the channel wall define an angled counterbore adapted to impart a radially asymmetric bias to the meniscus of the body fluid when the fluid is within the capillary channel.

7. The device of claim 6, wherein said bias tends to bias said fluid toward a testing element in spatial communication with said fluid.

8. The device of claim 7, wherein said testing element comprises a test strip.

9. The device of claim 8, wherein said test strip comprises a membrane.

10. The device of claim 8, wherein said test strip is mounted in a groove defined in said device.